Altimmune, Inc. Q3 FY2025 earnings call

Clinical Programs

• Pemvidutide's pipeline includes potential treatment for MASH, AUD, and ALD. Upcoming Q4 milestone of 48-week IMPACT data readout for MASH. In-person end of Phase II meeting with FDA in Q4 to review Phase III MASH program design. RECLAIM Phase II trial in AUD completed ahead of schedule. ALD Phase II trial started in Q3.

Leadership

• Recent additions to executive team: Dr. Christophe Arbet-Engels as Chief Medical Officer, Linda Richardson as Chief Commercial Officer, and Robin Abrahams as Chief Legal Officer.

Financials

• Cash at $211M as of September 30, 2025, with balance sheet strengthening. Amended Hercules debt agreement, filed $400M shelf registration and $200M ATM facility. R&D expenses $15M in Q3 2025 vs $19.8M in 2024; G&A expenses $5.9M in Q3 2025 vs $5M in 2024.

No detailed product segment financial performance with revenue contribution % provided in the transcript.

Milestones

• Anticipated 48-week IMPACT data readout in Q4.
• Preparation for in-person end of Phase II meeting with FDA in Q4 to finalize Phase III MASH program design.
• RECLAIM trial in AUD completed ahead of schedule; ALD Phase II trial ongoing.

Uncertainties

• Forward-looking statements subject to risks and uncertainties as per SEC filings.
• Regulatory uncertainties regarding clinical trial endpoints and approvals.
• Competition from other therapies in the MASH, AUD, and ALD spaces.

Q: Congrats for all the progress. Maybe a couple of question. First is on the upcoming 48-week data from the Phase II IMPACT MASH. So how much of the data will inform your conversation with the FDA and then also the Phase III design? And then what's the current thinking about the Phase III in terms of the 24 versus the 48-week time point and then the NIT and AI biopsy-driven AI-based biopsy endpoints?

A: Yes. Roger, thank you for the question. So as far as the end of Phase II meeting with the FDA is concerned, as you know, the end of Phase II meeting was requested on the basis of the 24-week data. So really, there would not be any 48-week data that would be part of that discussion at this point. Obviously, we will submit 48-week data when that's available. But we believe and apparently, the FDA agrees with us that we have sufficient data at 24-week to request and now FDA has granted a meeting to us on the basis of that data. So, I think we're in a good shape. Christophe, did you want to add anything to that?

Q: And congrats on the RECLAIM enrollment completion. I guess the first question is based on sort of discussion with the key opinion leaders in the space, do you have any idea in like, I guess, the probability of the different scenarios of potentially using NITs or AI-based histological reading. If you could just maybe help us understand based on the 3 scenarios, which one they think has a high probability of being able to get a sign-off. That's question one. And then question two is, help us understand, I guess, the advantages of using AI-based biopsy reading versus traditional histology reading and especially when it comes to Phase III studies and if any other sponsors have implemented that? And then the third question is on RECLAIM, maybe help us conceptualize what would be considered a clinically meaningful endpoint in the primary endpoint there.

A: All right. So, I will start with the NITs. The NITs, there are a lot of different discussions ongoing at this point in time. We're going to -- we are aware that some of these discussions will occur with the AASLD meeting coming up at the end of this week, and we will learn more around that. We know the FDA is looking through the -- at this very closely. And there is -- from our understanding, there is an increasing interest to look at those NITs. So as Vipin shared, we are designing our Phase III in order to really have the flexibility to adapt to any changes on the regulatory landscape. On the AI, there are differences. The histopathologist in general, look at a narrow part of the slides and estimate the level of fibrosis based on a number of criteria, but that introduces quite a large amount of variability and the AI on the other aspect look at the total area of fibrosis and doesn't quantify the stages only, but allows just a gradual and more comprehensive evaluations of the slides. So, this is something that allows for rapid evaluations with less variability. And we know that this has been already approved by the EMA as an approach to look at the biopsies. And the last -- the third point was, I'm not sure I fully heard the questions on the primary endpoint if you, that was… Q: I was hoping you could talk a little bit about alcoholic use disorder and alcoholic liver disease as distinct opportunities. It just seems like there's going to be significant overlap in the advantages or disadvantages of running one program versus both.

A: Yes, that's a great question, Jonathan. So, I mean, that's the reason we decided to expand the program into AUD and ALD because we believe there is significant opportunity in both of those, and we could be sort of the frontrunner in terms of driving value proposition, additional value proposition for pemvidutide. So, it's not just MASH, AUD and ALD. These are very similar product profile that we are looking for in terms of having this dual mechanism of action working directly in the liver, as well as in case of AUD having reduction of cravings. So, bringing these multiple features together is really important. AUD typically leads to ALD. So, AUD and ALD go hand-in-hand. So, the idea here is that if we can get -- if we can show success in AUD chances that will also be successful in ALD. We've actually already shown the endpoint that we used in MASH one of the NITs is what would be the endpoint for ALD. So, we already have some idea that the drug is working on these endpoints. So, we're very excited about these additional that can be developed independent of MASH beyond MASH.